This is a prospective, multi-center clinical trial to characterize the safety and pharmacokinetics of four oral anti-epileptics drugs (levetiracetam, valproic acid, topiramate, and oxcarbazepine) in obese children and adolescents (ages 2-18 years old). The study's duration will be up to 14 days (up to seven days of screening and seven days of pharmacokinetic sampling).

AEGIS-II is a phase 3 Acute Coronary Syndrome study which will be evaluating the efficacy and safety of CSL112 on reducing the risk of major adverse cardiovascular events in high risk patients with ACS (diagnosed with STEMI or NSTEMI) who are receiving evidence-based medical therapy. The study is sponsored by CSL-Behring and is being managed in collaboration with global academic groups and a global CRO.

The ARAMIS registry is designed to provide important and timely insight into the management of acute stroke patients who are on new oral anticoagulants in community practice.

ClinicalTrials.gov Identifier: NCT02478177Sponsor: Janssen, Genentech, and Daiichi SankyoRecruiting: Patients
(*Sites must be participating in Get With the Guidelines -Stroke)Contact for Information:
Khaula Balochkhaula.baloch@duke.edu
(919) 668-8909

The CARRA Registry is an observational study of subjects with the onset of rheumatic disease prior to age 16 years for juvenile idiopathic arthritis and onset prior to age 19 years for all other rheumatic diseases. The Registry will enroll 10,000 patients and follow the patients for a 10-year period. The data will be collected semi-annually. The primary objective is to prospectively collect essential data from children, adolescents and young adults with pediatric onset rheumatic diseases; and evaluate the safety of therapeutic agents in these subjects.

CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial that will enroll 8,000 people with heart failure at 160 hospitals across the United States. The primary objective of CONNECT-HF is to evaluate the effect of two quality-improvement initiatives compared to usual care on HF outcomes and HF quality-of-care metrics at 1 year after discharge.

Pediatric CABP Study:A Phase 2/3, Randomized, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents (12 to 17 years of age, inclusive) and Children (≥2 months to <12 years of age) with Community-Acquired Bacterial Pneumonia (CABP)

TACT2 will build on the positive results of TACT1, an NIH-sponsored multicenter, double-blind efficacy and safety trial for edetate disodium (EDTA) chelation therapy in individuals with coronary artery disease. Plans for TACT2 include targeting the population of patients who received the greatest benefits from EDTA treatment (those with a prior heart attack and diabetes) and also to determine if the positive results from TACT1 can be replicated in diabetic patients who have experienced a myocardial infarction, a particularly high-risk group of patients in need of effective therapy.

TARGET-HFDM: Technology to improve drug Adherence and Reinforce Guideline based Exercise Targets in patients with Heart Failure and Diabetes Mellitus

TARGET-HFMD is a multi-site study in the U.S. evaluating the utility of mHealth tools to improve physical activity and medication adherence in patients with chronic heart failure and diabetes mellitus.

The primary objective of the study is to describe the efficacy of 0.25% and 0.5% topical timolol maleate gel forming solution (GFS) as assessed through IH changes in volume. The secondary objective is to describe the safety and pharmacokinetics (PK) of topical timolol maleate GFS for treatment of IH.

VIVID is a clinical randomized trial using patient-centered racially distinct educational videos on Sudden Cardiac Death and ICD therapy in African American patients, comparing the effect of the video intervention vs. usual care, to look at the decision for ICD implantation and the effect of racial concordance on the decision for ICD implantation. VIVID is consenting, randomizing, collecting all PROs, and administering the video intervention via an iPad, using the VIVID iPad application.

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